Lung Cancer
Conditions
Keywords
Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Voice Response System, Questionnaire, Survey, NSCLC
Brief summary
Primary Objectives: * To compare the effectiveness of an interactive voice response (IVR) telephone triage/feedback system versus an interactive voice response telephone system with assessment only in monitoring and managing symptoms in patients with advanced non small cell lung cancer (NSCLC). * To compare differences in mood and quality of life variables of patients using the IVR triage/feedback system versus IVR assessment only. * To compare the healthcare utilization (emergency visits, admissions, length of stay for hospitalizations for uncontrolled symptoms) of patients using the IVR triage/feedback system versus IVR assessment only.
Detailed description
You will be asked to complete several questionnaires during a visit to the Thoracic Clinic. These questionnaires measure physical and emotional symptoms, and quality of life. Completing the questionnaires takes about 30-45 minutes. The research nurse will also teach you how to use the telephone system for reporting symptoms. You will tell the research nurse when the most convenient times for the telephone calls and the telephone system will be set up to call at those times. It is not clear at this time whether the telephone symptom evaluation is better than the usual plan that doctors and nurses follow for asking about symptoms. For this reason, you will be randomly picked (as in the toss of a coin) to be in one of two groups. The chance of being in either one of the two programs is about equal. Half of the patients will be assigned to the telephone assessment system plus triage group. If you are assigned to this group, you will report symptoms to the telephone system and the doctor or nurse at M.D. Anderson will be notified when a symptom is severe. You will also be encouraged to report all symptoms to their doctor and nurse at M.D. Anderson. Half of the patients will be assigned to the telephone assessment only group. If you are assigned to this group, your symptom information will only be given through the telephone system. You will also be encouraged to report all symptoms directly to your doctor and nurse at M.D. Anderson. Your physician may request information from the telephone system. If you are assigned to this telephone assessment only group, the telephone system will call you twice a week during 2 cycles of chemotherapy. It is programmed to ask you to rate your symptoms and how much the symptoms interfere in your life. Rating symptoms using the telephone system takes less than five minutes for each call. After each chemotherapy cycle, you and patients in both groups will be asked to fill out questionnaires during a clinic visit. The questionnaires are used to measure emotional symptoms and quality of life. Completing the questionnaires takes about 15-30 minutes. Your medical charts will also be reviewed and information collected about medical history. If you have agreed to participate in the companion caregiver study, the study staff will use your demographic and clinical data to study the influence of your symptoms on your caregiver's physical and mental health. This is an investigational study. About 100 will be enrolled at M.D. Anderson Cancer Center. A total of 136 patients will take part in this multicenter study.
Interventions
BEHAVIORALQuestionnaire
Questionnaires taking about 30-45 minutes to complete.
BEHAVIORALInteractive Voice Response Telephone System
IVR Only = Phone calls twice weekly, each call lasting less than 5 minutes.
BEHAVIORALIVR Plus Triage
IVR system will triage, or sort, the symptom data by symptom severity, notifying health care professionals when a symptom is greater than the set threshold limit.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with stage III or IV non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC) (Patients who have received other prior chemotherapy are eligible.) * 18 years of age or older * English-speaking * Lives in the United States * Adequate vision and hearing to use the Interactive Voice Response (IVR) system * Provides written informed consent
Exclusion criteria
* Current diagnosis of psychosis or dementia * Patients unable to complete the assessment measures or unable to understand the purpose of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of Number of Alerts Generated by Symptom Distress Over the Number of Available Assessments | Baseline to end of first chemotherapy cycle (generally chemotherapy and 1 assessment of response within 6-8 weeks) | Total number of alerts generated by symptom exceeding prespecified threshold for 7 symptoms - pain, fatigue, nausea, cough, constipation, vomiting and shortness of breath (Ratio alerts/number of assessments using IVR telephone triage/feedback versus IVR only). Reporting 0-10 severity scale of MD Anderson Symptom Inventory from 0 (symptom not present) to 10 (symptom bad as imagine it could be). Thresholds set at 4 on scale for all symptoms except shortness of breath and constipation where threshold set at 2. More than one symptom alert may appear per assessment causing ratio values to exceed 1. |
Countries
United States
Participant flow
Recruitment details
Recruitment Period: 04/30/03 to 12/10/08. All participants recruited at UT MD Anderson Cancer Center.
Pre-assignment details
Of 84 enrolled, 16 participants dropped out before baseline assessment, prior to group assignment. Baseline data analysis was done on the remaining 68 patients (35 in the intervention and 33 in the control group).
Participants by arm
| Arm | Count |
|---|---|
| IVR Assessment Plus Triage Interactive Voice Response Telephone System (IVR) Plus Triage (Participants report symptoms to telephone system and doctor/nurse notified when symptom is severe) + Questionnaire | 35 |
| IVR Assessment Only IVR (Phone calls twice weekly) + Questionnaire | 33 |
| Total | 68 |
Baseline characteristics
| Characteristic | IVR Assessment Plus Triage | IVR Assessment Only | Total |
|---|---|---|---|
| Age Continuous | 64.41 years STANDARD_DEVIATION 9.11 | 60.63 years STANDARD_DEVIATION 8.4 | 62.5762 years STANDARD_DEVIATION 8.9158 |
| Region of Enrollment United States | 35 participants | 33 participants | 68 participants |
| Sex: Female, Male Female | 18 Participants | 18 Participants | 36 Participants |
| Sex: Female, Male Male | 17 Participants | 15 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 35 | 0 / 33 |
| serious Total, serious adverse events | 0 / 35 | 0 / 33 |
Outcome results
Primary
Ratio of Number of Alerts Generated by Symptom Distress Over the Number of Available Assessments
Total number of alerts generated by symptom exceeding prespecified threshold for 7 symptoms - pain, fatigue, nausea, cough, constipation, vomiting and shortness of breath (Ratio alerts/number of assessments using IVR telephone triage/feedback versus IVR only). Reporting 0-10 severity scale of MD Anderson Symptom Inventory from 0 (symptom not present) to 10 (symptom bad as imagine it could be). Thresholds set at 4 on scale for all symptoms except shortness of breath and constipation where threshold set at 2. More than one symptom alert may appear per assessment causing ratio values to exceed 1.
Time frame: Baseline to end of first chemotherapy cycle (generally chemotherapy and 1 assessment of response within 6-8 weeks)
Population: Analysis was per protocol. Due to attrition, data from 61 participants were analyzed at end of first chemotherapy cycle and from 27 participants at the end of the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IVR Assessment Plus Triage | Ratio of Number of Alerts Generated by Symptom Distress Over the Number of Available Assessments | 0.96 Ratio of alerts/number of assessments |
| IVR Assessment Only | Ratio of Number of Alerts Generated by Symptom Distress Over the Number of Available Assessments | 1.56 Ratio of alerts/number of assessments |